Kyprolis for Multiple Myeloma (relapsed) – Details

In combination with dexamethasone alone in the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy

Review Status

Notification to Implement Issued

Pre Noc Submission

Yes

NOC Date

November 22, 2016

Manufacturer

Amgen Canada Inc.

Submitter

Amgen Canada Inc.

Submission Date

September 9, 2016

Submission Deemed Complete

September 16, 2016

Submission Type

New Indication

Prioritization Requested

Not Requested

Stakeholder Input Deadline ‡

September 23, 2016

Check-point meeting

November 1, 2016

pERC Meeting

January 19, 2017

Initial Recommendation Issued

February 2, 2017

Feedback Deadline ‡

February 16, 2017

pERC Reconsideration Meeting

March 16, 2017

Final Recommendation Issued

March 30, 2017

Notification to Implement Issued

April 17, 2017

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.